What is USP?
USP <795> provides the minimum standards for preparing compounded nonsterile preparations (CNSPs).
Who is enforcing USP?
Enforcement is left to regulatory and credentialing entities who have decided to require USP <795> compliance for nonsterile compounding. The following entities may require your pharmacy to follow USP <800>:
- State Boards of Pharmacy
- Accreditation Organizations
- Payers
- Other Contracting Entities
Additionally, entities like NCPDP are asking whether your pharmacy complies with USP <795>.
What is a nonsterile compound?
USP <795> covers the compounding of the following products:
- Solid oral Preparations
- Liquid oral preparations
- Rectal preparations
- Vaginal preparations
- Topical Preparations (i.e., creams, gels, and ointments
- Nasal and sinus preparations intended for local applications (i.e., nasal sprays and nasal irrigation
- Otic preparations (excluding use in perforated eardrums)
USP <795> does not cover:
- Sterile Compounding
- Nonsterile Radiopharmaceuticals
- Reconstitution
- Repackaging
- Splitting Tabs
What is USP795Track?
The PRS USP795Track Compliance Program is designed to make your Pharmacy Compliant with the USP <795> Standards for Nonsterile Compounds. The program contains all the policies, procedures, forms, and training (based on the regulation and the policies and procedures) to ensure you have the tools to comply. The comprehensive USP795Track Program from PRS includes the following:
- Compliance Guide to walk you through implementation
- Customizable Policies and Forms:
- Compounding Coordinator
- Building and Facility Policies
- Compounding Equipment
- Cleaning and Sanitization
- Compounding Components
- Beyond Use Dating
- Inventory Management
- Master Formulation Records
- Compounding process
- Adverse Events
- Quality Assurance and Controls
- And more
- Online Employee Training covering the Policies
What is USP?
USP <800> provides the minimum standards for addressing hazardous drugs (HDs) to promote patient safety, worker safety, and environmental protection while receiving, handling, storing, administering, dispensing, and disposing of HDs.
Who is enforcing USP?
Enforcement is left to regulatory and credentialing entities who have decided to require USP <800> compliance. The following entities may require your pharmacy to follow USP <800>:
- State Boards of Pharmacy
- Business and Liability Insurance
- Accreditation Organizations
- Other Contracting Entities
Additionally, entities like NCPDP are asking whether your pharmacy complies with USP <800>.
Knowing when these entities are enforcing USP <800> is essential. In most cases, USP <800> is enforced only during the compounding process.
What is a Hazardous Drug?
Drugs are considered Hazardous, according to NIOSH, if they exhibit any of the following:
- Carcinogenicity
- Teratogenicity or developmental toxicity
- Reproductive toxicity
- Genotoxicity
- Structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous by the above criteria
There are currently over 220 hazardous drugs on the NIOSH list. While many of these medications are antineoplastic medications, there are some very common medications that your pharmacy probably dispenses every day, including:
- carbamazepine
- divalproex
- estrogens
- fluconazole
- medroxyprogesterone
- paroxetine
- phenytoin
- tamoxifen
- testosterone
- warfarin
You can find a complete list of Hazardous Drugs on the NIOSH Website here.
What is USP800Track?
The PRS USP800Track Compliance Program is designed to make your Pharmacy Compliant with the USP <800> Standards for handling Hazardous Drugs in the Pharmacy (compounding and non-compounding). The program contains all the policies, procedures, forms, and training (based on the regulation and the policies and procedures) to ensure you have the tools to comply. The comprehensive USP800Track Program from PRS includes the following:
- Compliance Guide to walk you through implementation
- Customizable Policies and Forms:
- Hazardous Drug Manager
- Hazardous Drug Inventory
- Customizable Assessment of Risk Templates
- Personal Protective Equipment
- Engineering Controls
- Spills and Cleanup
- Reproductive Acknowledgements
- Medical Surveillance
- And more
- Online Documentation of Your Hazardous Drug Inventory
- Online Employee Training covering the policies